UNK NI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-09-02 for UNK NI manufactured by Unk.

Event Text Entries

[20886307] Rptr writes, "two fda approved procedures to shrink the prostate have left me devastated, in constant pain and agony, while increasing the size of my prostate. On or about jan 30, 1997, dr performed transurethral microwave therapy (tumt) on me. On may 14, 1997, dr utilized transurethral needle ablation (tuna) on my body. These 2 procedures should never have been done. "
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1014512
• MDR Report Key: 185440
• Date Received: 1998-09-02
• Date of Report: 1998-08-31
• Date Added to Maude: 1998-09-08
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: UNK
• Generic Name: TRANS URETHRAL MICROWAVE THERAPY DEVICE
• Product Code: MEQ
• Date Received: 1998-09-02
• Model Number: NI
• Catalog Number: NI
• Lot Number: NI
• ID Number: NI
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 180252
• Manufacturer: UNK
• Manufacturer Address: UNK UNK UNK *

Device Sequence Number: 2

• Brand Name: UNK
• Generic Name: TRANS URETHRAL NEEDLE ABLATION DEVICE
• Product Code: MIK
• Date Received: 1998-09-02
• Model Number: NI
• Catalog Number: NI
• Lot Number: NI
• ID Number: NI
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 2
• Device Event Key: 180253
• Manufacturer: UNK
• Manufacturer Address: UNK UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1998-09-02